When drugs and nutritional supplements on the U.S. market pose dangers to the health of patients and consumers, the U.S. Food and Drug Administration (FDA) may initiate a recall for the product or ask the drug’s manufacturer to voluntarily issue pharmaceutical recall notices. When injuries are involved, lawsuits quickly follow recalls.
The Lyon Firm is dedicated to reviewing every individual case that shows an association between a specific injury or condition and a drug, whether over-the-counter or prescribed. The Lyon Firm has experienced engaging large drug corporations in product liability litigation and files personal injury lawsuits on behalf of plaintiffs nationwide.
If in fact you are suffering from a certain medication, or have been injured through the use of a prescribed drug, contacting a pharmaceutical recall lawyer is the next step if you want to seek compensation for medical costs, lost wages, and pain and suffering.
The Lyon Firm has the resources and access to industry experts required to effectively pursue damages against the responsible parties.
Negligent Drug Companies
Recalled defective drugs may result from improper testing, lab contamination, or production mishaps. Warnings may be issued by the nation’s safety agencies, typically after a series of complaints about health issues linked to the drug. A drug company may list several side effects on a drug label, but may understate the dangers or overhype the benefits of a particular drug.
The Food and Drug Administration is charged with the responsibility of ensuring the safety of the millions of consumers using thousands of medications and supplements.
It is impossible for the FDA to completely prevent the sale of harmful pharmaceuticals and each year thousands of patients suffer injuries. Consequently, victims and their attorneys file lawsuits targeting the manufacturers and distributors of these drugs. Major drug makers are regularly linked to recalled pharmaceuticals, including the following:
- Bristol-Meyers Squibb
- Teva Pharmaceuticals
- Abbott Labs
- Johnson & Johnson
Defective Drug Lawsuits
When consumers are harmed by drugs brought to market by the reckless practices and negligence of pharmaceutical companies, the companies may be held liable for the disregard of public health. Drug companies have a duty to protect the well-being of patients, or they must compensate for damages that result when their products are found to be dangerous.
If the drug you are taking has caused an injury or has been recalled, contact a healthcare professional and an experienced attorney to assist you in the necessary medical and legal proceedings. To build the strongest case possible, it is crucial to keep personal and medical records related to your specific drug injury.
Joe Lyon is a highly-rated toxic tort and personal injury lawyer representing plaintiffs nationwide in a wide variety of product liability claims and class action pharmaceutical recall lawsuits against negligent pharmaceutical companies.
Types of Pharmaceutical Recall
- SGLT-2 Inhibitors
- Proton pump inhibitors (PPIs)
- Chemotherapy medications
- Weight Loss Drugs
- Angiotensin II receptor blockers (ARBs)
FDA Pharmaceutical Recall
Drug and medication recalls are far from rare, and the FDA announces hundreds of pharmaceutical recalls each year due to contamination, health risks, improper packaging, failures to warn consumers of injury, cancer risks, allergen concerns, and other defects.
Following preventable drug injuries in which the substance was recalled and known to be defective, victims and their families can hire an experienced product safety lawyer to investigate and file injury claims.
Negligent physicians and drug manufacturers may be liable for related injuries and injured plaintiffs are encouraged to hold negligent parties accountable. Plaintiffs may be eligible for large settlements and compensation for defective drug treatment, medical expenses, and pain and suffering.
Given the large reach of pharmaceutical marketing practices and budgets, drugs can affect the health and lives of thousands of patients in both good and bad ways. Pharmaceutical recall litigation is a necessary balance to contain the large marketing budgets and influence of pharmaceutical companies.
Defective Pharmaceutical Products present an extremely dangerous public health risk and often lead to large scale and complex pharmaceutical litigation. Pharmaceutical litigation is a deterrent against corporations cutting corners and a means to compensate those who have been unjustly harmed by a dangerous product.
Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance.
Very simply, the volume of drugs that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.
While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval should not be a shield for liability.
Some recalled drugs include:
Drug Injury & Pharmaceutical Recalls
When drugs are prescribed and do not work as intended because of a defect, serious injuries and complications may result. Depending on the particular drug, dosage, and seriousness of the defect, injuries and adverse health effects can vary widely.
Some of the more serious conditions developed from dangerous pharmaceuticals may include serious addiction, increased risk of amputations, cardiac risks, and death. Other medication related injuries may include:
- Aortic Dissection
- Liver Damage
- Heart failure
- Muscle Spasms
- Fournier’s Gangrene Infection
- Severe Allergic Reactions (DRESS)
- Kidney Failure
- Nerve damage
- Vision problems
- Gastrointestinal tract toxicity
- Cancer Risk
Pharmaceutical Injury Settlements
Each year, hundreds of new drugs and dietary supplements are sold to the American public with approval from the U.S. Food and Drug Administration (FDA). Some drug companies, however, fail to properly test their products before they are prescribed by doctors and consumed by patients over-the-counter.
When drug companies are negligent in releasing contaminated or dangerous products and fail to warn doctors and patients, they may be held liable by injured plaintiffs and your Ohio product safety lawyer in product liability lawsuits. Settlements can be sought and compensation for medical expenses, pain and suffering and long-term disability can be sizable.
Contaminated and unsafe drugs end up leading to severe side effects and complications that drug companies may or may not have known about, resulting in warnings and product recalls. Consumers end up injured or ill and pharmaceutical companies may be liable for subsequent damages and personal injury and product liability lawsuits filed by a pharmaceutical recall lawyer.
If you discover that a drug you are taking has been recalled, the first step is to contact a physician to determine whether you are suffering harmful side effects associated with the recalled drug. Noted side effects may be mild or severe, but regardless, you and your doctor should discuss the possibility of an alternative medication.
Why are these cases important?
Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.
Give Yourself a Voice
Questions about Pharmaceutical Recall Cases
Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.
While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.
Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product. The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.
Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.
Current Examples of Pharmaceutical Litigation.
Opioid Crisis: The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis.
Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.
Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.
It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients.
Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.
Antibiotics: Antibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.
Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.
Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.
Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.
Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol. Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.
In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure. After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.
Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement. In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.
Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.
Pharmaceutical Injury Cases are Typically Consolidated in an MDL.
Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not class action lawsuits, but they are very similar.
Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.
Federal Courts Utilize the MDL Process to Consolidate Pharmaceutical Injury Cases.
The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts. While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.
The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.
Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.
Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.
In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.
Absolutely. If a pharmaceutical company sells a product that is improperly tested or fails to warn of certain health risks, and an injury occurs, a lawsuit may be filed.